BACKGROUND OF THE INVENTION
[0001] The present invention relates to the field of microwave thermal therapy of tissue.
In particular, the present invention relates to a device for transurethral microwave
thermal therapy of benign prostatic hyperplasia (BPH), as stated in the preamble of
claim 1.
[0002] The prostate gland is a complex, chestnut-shaped organ which encircles the urethra
immediately below the bladder. Nearly one third of the prostate tissue anterior to
the urethra consists of fibromuscular tissue that is anatomically and functionally
related to the urethra and bladder. The remaining two thirds of the prostate is generally
posterior to the urethra and is comprised of glandular tissue.
[0003] This relatively small organ, which is the most frequently diseased of all internal
organs, is the site of a common affliction among older men: BPH (benign prostatic
hyperplasia). BPH is a nonmalignant, bilateral nodular expansion of prostrate tissue
in the transition zone, a periurethral region of the prostate between the fibromuscular
tissue and the glandular tissue. The degree of nodular expansion within the transition
zone tends to be greatest anterior and lateral to the urethra, relative to the posterior-most
region of the urethra. Left untreated, BPH causes obstruction of the urethra which
usually results in increased urinary frequency, urgency, incontinence, nocturia and
slow or interrupted urinary stream. BPH may also result in more severe complications,
such as urinary tract infection, acute urinary retention, hydronephrosis and uraemia.
[0004] Traditionally, the most frequent treatment for BPH has been surgery (transurethral
resection). Surgery, however, is often not an available method of treatment for a
variety of reasons. First, due to the advanced age of many patients with BPH, other
health problems, such as cardiovascular disease, can warrant against surgical intervention.
Second, potential complications associated with transurethral surgery, such as hemorrhage,
anesthetic complications, urinary infection, dysuria, incontinence and retrograde
ejaculation, can adversely affect a patient's willingness to undergo such a procedure.
[0005] A fairly recent alternative treatment method for BPH involves microwave thermal therapy,
in which microwave energy is employed to elevate the temperature of tissue surrounding
the prostatic urethra above about 45°C, thereby thermally damaging the tumorous tissue.
Delivery of microwave energy to tumorous prostatic tissue is generally accomplished
by a microwave antenna-containing applicator, which is positioned within a body cavity
adjacent the prostate gland. The microwave antenna, when energized, heats adjacent
tissue due to molecular excitation and generates a cylindrically symmetrical radiation
pattern which encompasses and necroses the tumorous prostatic tissue. The necrosed
intraprostatic tissue is subsequently reabsorbed by the body, thereby relieving an
individual from the symptoms of BPH.
[0006] One method of microwave thermal therapy described in the art includes intrarectal
insertion of a microwave antenna-containing applicator. Heat generated by the antenna's
electromagnetic field is monitored by a sensor which is positioned near the prostate
gland by a urethral catheter. Owing to the distance between the rectus and the tumorous
prostatic tissue of the transition zone, however, healthy intervening tissue within
the cylindrically symmetrical radiation pattern is also damaged in the course of the
intrarectal treatment. Intrarectal microwave thermal therapy applicators are described
in the following references: Eshel et al. U.S. Patent 4,813,429; and, A. Yeruahalmi
et al.,
Localized Deep Microwave Hyperthermia in the Treatment of Poor Operative Risk Patients
with Benign Prostatic Hyperplasia, 133 JOURNAL or UROLOGY 873 (1985).
[0007] A safer and more efficacious treatment of BPH is transurethral microwave thermal
therapy. This method of treatment minimizes the distance between a microwave antenna-containing
applicator and the transition zone of the prostate by positioning a Foley-type catheter-bearing
applicator adjacent to the prostate gland within the urethra. Due to the close proximity
of the microwave antenna to the prostate, a lesser volume of tissue is exposed to
the cylindrically symmetrical radiation pattern generated by the microwave antenna,
and the amount of healthy tissue necrosed is reduced. Intraurethral applicators of
the type described can be found in Turner et al. U.S. Patent 4,967,765 and Hascoet
et al. European Patent Application 370 890, the latter document forming the state
of the art as expressed by the preamble of claim 1. Other conventional methods which
refer to the use of microwave energy to treat BPH are disclosed in Japanese utility
model 5-61-15903, Japanese patent H-4-28377 and US 4, 601, 296.
[0008] While the close proximity of a transurethral microwave thermal therapy applicator
to prostatic tissue reduces the amount of damage to healthy tissue, controlling the
volume of tissue to be affected by the microwave energy field continues to be problematic.
For instance, microwave antennas known in the art have tended to produce electromagnetic
fields which affect a volume of tissue, beyond the desired area of treatment, which
necroses healthy, normal tissue.
SUMMARY OF THE INVENTION
[0009] The present invention is based upon the recognition that in patients suffering from
BPH, tumorous tissue growth within the prostate tends to be the greatest in the portion
of the transition zone anterior and lateral to the urethra. The present invention
is a transurethral thermal therapy catheter for thermal treatment of BPH which is
capable of selectively directing microwave energy toward tumorous prostatic tissue
growth anterior and lateral to the urethra, while sparing the urethra and healthy
tissue posterior to the urethra from thermal damage.
[0010] Thus the device according to the invention is characterised as stated in the main
claim. The different dimensions in a radial direction form a distinct difference with
the state of the art according to EP-A-0 370 890 which does not shows such a feature.
[0011] The catheter preferably includes a flexible shaft which contains a multiplicity of
lumens that extend the length of the shaft. A relatively large lumen is located eccentric
to a longitudinal axis of the shaft, near a first side of the shaft, and is provided
for a microwave antenna. The microwave antenna is connected to a microwave generator
by a coaxial cable, and is bonded within the antenna lumen. Microwave energy emitted
by the antenna is capable of producing a cylindrically symmetrical radiation pattern
which is concentrated about the antenna. Temperatures within a target area of the
radiation pattern exceed about 45°C, which effectively necrose the irradiated tissue.
[0012] Cooling lumens, which communicate at a proximal end of the shaft, encircle the antenna
lumen and are circumjacent an outer surface of the shaft. Water intake lumens adjacent
the first side of the shaft are relatively narrow in cross-section, while water exhaust
lumens adjacent a second side of the shaft are relatively wide in cross-section. Cooled
water from a cooling system is pumped into the water intake lumens at a distal end
of the shaft. The water flows to the proximal end of the shaft and returns to the
cooling system via the water exhaust lumens. The water within the cooling lumens protects
tissue immediately adjacent the outer surface of the shaft when the antenna is energized
by absorbing heat energy from the adjacent tissue (i.e. thermal conduction). The water
within the cooling lumens also alters the radiation pattern generated by the antenna
by absorbing some of the microwave energy emitted by the antenna. Water in the wider
exhaust lumens near the second side of the shaft absorbs a greater amount of microwave
energy than water in the narrower intake lumens near the first side of the shaft.
As a result, the radiation pattern generated by the microwave antenna (and therefore
the pattern of thermal energy delivered) becomes asymmetrical, with a target area
of tissue adjacent the first side of the shaft being heated above about 45°C, and
the tissue adjacent the second side of the shaft remaining below about 45°C.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013]
Fig. 1 is a vertical sectional view of a male pelvic region showing the urinary organs
affected by benign prostatic hyperplasia.
Fig. 2A is a side view of the distal end of the urethral catheter of the present invention.
Fig. 2B is an enlarged sectional view of the proximal end of the urethral catheter
of the present invention.
Fig. 3 is a cross-sectional view of the urethral catheter of Fig. 2B taken along line
3-3.
Fig. 4 is a perspective view of a proximal region of the urethral catheter with the
end portion taken in section from line 4-4 of Fig. 2B.
Fig. 5 is an enlarged view of the male pelvic region of Fig. 1 showing the urethral
catheter of the present invention positioned within the prostate region.
Fig. 6 is a graph illustrating temperature distribution generated by the catheter
of the present invention as a function of time.
Fig. 7 is a partial sectional view of the microwave antenna of the urethral catheter
of the present invention.
Fig. 8 is an exploded view of the microwave antenna shown in Fig. 7.
Fig. 9 is a block diagram of the transurethral microwave thermal therapy system of
the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0014] Fig. 1 is a vertical sectional view of a male pelvic region showing the effect benign
prostatic hyperplasia (BPH) has on the urinary organs. Urethra 10 is a duct leading
from bladder 12, through prostate 14 and out orifice 16 of penis end 18. Benign tumorous
tissue growth within prostate 14 around urethra 10 causes constriction 20 of urethra
10, which interrupts the flow of urine from bladder 12 to orifice 16. The tumorous
tissue of prostate 14 which encroaches urethra 10 and causes constriction 20 can be
effectively removed by heating and necrosing the encroaching tumorous tissue. Ideally,
with the present invention, only periurethral tumorous tissue of prostate 14 anterior
and lateral to urethra 10 is heated and necrosed to avoid unnecessary and undesirous
damage to urethra 10 and to adjacent healthy tissues, such as ejaculatory duct 24
and rectum 26. A selective heating of benign tumorous tissue of prostate 14 (transurethral
thermal therapy) is made possible by microwave antenna-containing catheter 28 of the
present invention, which is shown in Figs. 2A and 2B.
[0015] Fig. 2A shows a side view of a distal end of catheter 28. Fig. 2B shows an enlarged
sectional view of a proximal end of catheter 28. As shown in Figs. 2A and 2B, catheter
28 generally includes multi-port manifold 30, multi-lumen shaft 32, shaft position
retention balloon 34, connection manifold 35, cooling system 36 and microwave generating
source 38.
[0016] Manifold 30 includes inflation port 40, urine drainage port 42, microwave antenna
port 44, cooling fluid in port 46 and cooling fluid out port 48. Ports 40-48 communicate
with corresponding lumens within shaft 32. Manifold 30 is preferably made of medical-grade
silicone sold by Dow Corning under the trademark silastic Q-7-4850.
[0017] Shaft 32 is connected to manifold 30 at shaft distal end 50. Shaft 32 is a multi-lumen,
Foley-type urethral catheter shaft which is extruded from a flexible, medical-grade
silicone sold by Dow Corning under the trademark Silastic Q-7-4850. Shaft 32, which
has an outer diameter of about 5.3 mm (16 French), includes outer surface 52, which
is generally elliptical in cross-section as shown in Fig. 3. Shaft 32 is long enough
to permit insertion of proximal shaft end 54 through urethra 10 and into bladder 12.
In one preferred embodiment, shaft 32 is coated with a hydrophilic solution sold by
Hydromer, Inc. under the mark Hydromer, which lubricates outer surface 52 of shaft
32 and facilitates its advancement within urethra 10.
[0018] As shown in Figs. 2B-4, shaft 32 includes temperature sensing lumen 56, microwave
antenna lumen 58, urine drainage lumen 60, balloon inflation lumen 62, cooling fluid
intake lumens 64A and 64B, and cooling fluid exhaust lumens 66A and 66B. Lumens 56-66B
generally extend from distal shaft end 50 to proximal shaft end 54.
[0019] Temperature sensing lumen 56 is positioned near first side 68 of shaft 32. Temperature
sensing lumen 56 communicates with microwave antenna port 44 and permits insertion
of thermometry sensor 69 within shaft 32 to monitor the temperature of surrounding
tissue when shaft 32 is inserted within urethra 10. Sensor 69 exits through port 44
and is connected through connection manifold 35 to urethral thermometry unit 178B
(shown in Fig. 9). In a preferred embodiment, thermometry sensor 69 is a fiber optic
luminescence type temperature sensor sold by Luxtron Corporation. Temperature sensing
lumen 56 is sealed at proximal end 54 by silicone plug 70.
[0020] Microwave antenna lumen 58 is eccentric to the longitudinal axis of shaft 32, antenna
lumen 58 being positioned nearer first side 68 of shaft 32 than second side 72 of
shaft 32. Antenna lumen 58 is sealed at proximal end 54 by silicone plug 70A. At its
distal end, antenna lumen 58 communicates with microwave antenna port 44. Microwave
antenna 74 is permanently positioned within antenna lumen 58 near balloon 34. Antenna
74 is positioned within antenna lumen 58 so as to be generally situated adjacent the
benign tumorous tissue of prostate 14 when shaft 32 is properly positioned within
urethra 10. As shown in Figs. 2A-2B, antenna 74 is bonded within antenna lumen 58
by adhesive bond 75. Antenna 74 is carried at the proximal-most end of coaxial cable
76. The distal-most end of coaxial cable 76 is connected to connection manifold 35
by a conventional quick-coupling fitting 73. Coaxial cable 76 communicates with microwave
generating source 38 by connection cable 76A, which is connected between microwave
generating source 38 and connection manifold 35. In one embodiment, connection cable
76A is a standard RG 400 coaxial cable. Microwave generating source 38 produces a
maximum of 100 watts of electrical power at about 915 MHz frequency, +/- 13MHz, which
is within the FCC-ISM standards. When antenna 74 is energized by microwave generating
source 38, antenna 74 emits electromagnetic energy which causes heating of tissue
within prostate 14.
[0021] Urine drainage lumen 60 is positioned adjacent antenna lumen 58, between antenna
lumen 58 and second side 72. Urine drainage lumen 60 communicates with urine drainage
port 42 and defines a drainage path for urine when proximal end 54 of shaft 32 is
inserted within bladder 12. Urine drainage lumen 60 is connected to urine drainage
lumen extension 78 at proximal end 54. Urine drainage lumen extension 78 is bonded
within proximal end cap 80. End cap 80 is further bonded over outer surface 52 of
shaft 32 at proximal shaft end 54, with cavity 82 surrounding lumen extension 78.
With end cap 80 and urine drainage lumen extension 78 in place, opening 84 to lumen
extension 78 permits urine to drain from bladder 12 through urine drainage lumen 60
and out urine drainage port 42 when proximal shaft end 54 is inserted within bladder
12. Drainage of urine from bladder 12 is necessary due to frequent bladder spasms
which occur during transurethral thermal therapy.
[0022] Balloon inflation lumen 62 is positioned near second side 72, generally between urine
drainage lumen 60 and second side 72. Balloon inflation lumen 62 communicates with
inflation port 40 and is sealed at proximal end 54 by silicone plug 70B. Balloon inflation
lumen 62 communicates with interior 86 of balloon 34 by opening 88.
[0023] Balloon 34, which is formed from a tubular section of a flexible, medical-grade silicone
sold by Dow Corning under the trademark Silastic Q-7-4720, is secured over shaft 32
by bonding balloon waists 90 and 92 over exterior surface 52 of shaft 32 near proximal
shaft end 54. Balloon 34 is inflated by an inflation device 188 (shown in Fig. 9),
which is connected to inflation port 40 and which supplies positive fluid pressure
to interior 86 of balloon 34. Balloon 34 is deflated when inflation device 188 supplies
a negative fluid pressure (i.e., a vacuum) to interior 86 of balloon 34. Balloon 34
serves to retain shaft 32 in a fixed position within urethra 10 when balloon 34 is
inflated within bladder 12 near bladder neck 22, as shown in Fig. 5.
[0024] As shown in Figs. 2B-4, cooling fluid intake lumens 64A, 64B are positioned circumjacent
first side 68, between first side 68 and antenna lumen 58. Cooling fluid intake lumens
64A, 64B extend from distal shaft end 50 to proximal shaft end 54 where lumens 64A,
64B are exposed to cavity 82 of end cap 80. Intake lumens 64A, 64B are relatively
narrow in cross-section and have a relatively small cross-sectional surface area.
Water contained within intake lumens 64A, 64B performs two essential functions. First,
water contained within lumens 64A, 64B absorbs some of the microwave energy emitted
by antenna 74. This assists, in part, in controlling the volume of tissue adjacent
first side 68 of shaft 32 that is heated above about 45° C. Second, the water within
lumens 64A, 64B absorbs heat energy generated by the microwave energy from adjacent
tissues (i.e., urethra 10) via thermal conduction. This prevents the portion of urethra
10 adjacent first side 68 from being overheated and damaged when antenna 74 is energized.
[0025] Cooling fluid exhaust lumens 66A, 66B are circumjacent second side 72 with lumens
66A, 66B generally positioned between second side 72 and antenna lumen 58. Like intake
lumens 64A, 64B, exhaust lumens 66A, 66B extend from shaft distal end 50 to shaft
proximal end 54 where exhaust lumens 66A, 66B are exposed to cavity 82 of end cap
80. Exhaust lumens 66A, 66B are wider in cross-section than intake lumens 64A, 64B,
and have a cross-sectional area greater than the cross-sectional area of intake lumens
64A, 64B. Water within exhaust lumens 66A, 66B is therefore capable of absorbing a
greater amount of microwave energy when antenna 74 is energized. As a result, for
a given power output from microwave generating source 38, the temperature of tissue
adjacent second side 72 will remain below about 45°C. Water within exhaust lumens
66A, 66B also absorbs heat energy from adjacent tissue (i.e., urethra 10) when antenna
74 is energized, which prevents the portion of urethra 10 adjacent second side 72
from being overheated and damaged when antenna 74 is energized.
[0026] Intake lumens 64A, 64B and exhaust lumens 66A, 66B are supplied with deionized water
from cooling system 36. Water from cooling system 36 is chilled to between about 12-15°C
and pumped at a rate of between about 100-150 milliliters per minute via water feed
line 94A to connection manifold 35. The water flows through connection manifold 35
to water feed line 94B and to water intake port 46, which communicates with water
intake lumens 64A, 64B. Under fluid pressure, the water circulates through intake
lumens 64A, 64B to cavity 82 of end cap 80. The water returns to cooling system 36
through exhaust lumens 66A, 66B to fluid exhaust port 48. The water is carried from
water exhaust port 48 via water return line 96B to connection manifold 35, and from
connection manifold 35 to cooling system 36 via water return line 96A. The water is
then re-chilled and re-circulated. Water feed line 94B and water return line 96B are
each provided with a conventional quick-coupling fitting 65A and 65B, respectively,
which permits catheter 28 to be easily disconnected from cooling system 36.
[0027] Fig. 5 shows an enlarged view of the male pelvic region of Fig. 1 with catheter 28
properly positioned within urethra 10. Orientation stripe 98 along exterior surface
52 on first side 68, as shown in Fig. 4, ensures the proper orientation of shaft 32
within urethra 10. As shown in Fig. 5, shaft 32 is positioned within urethra 10 with
second side 72 of shaft 32 oriented toward rectum 26. Water exhaust lumens 66A, 66B
are oriented posteriorly, toward rectum 26 and water intake lumens 64A, 64B are oriented
anteriorly toward fibromuscular tissue 100 of prostate 14. The portion of transition
zone 101 anterior and lateral to urethra 10 is the most frequent location of the tumorous
tissue growth which causes BPH. Since water exhaust lumens 66A, 66B are capable of
absorbing more microwave energy than water intake lumens 64A, 64B, the radiation patterns
created by microwave energy emitted from antenna 74 are asymmetrical. Thus, a relatively
large volume of tissue enveloping the anterior portion of transition zone 101, adjacent
first side 68, is heated to a temperature above about 45°C, which effectively necroses
the tumorous tissue of prostate 14 which encroaches upon urethra 10. In comparison,
the temperature of tissue adjacent second side 72 remains below about 45°C, thereby
eliminating the harmful effects of the microwave energy to ejaculatory duct 24 and
rectum 26.
[0028] Fig. 6 is a graph which generally demonstrates a microwave thermal therapy procedure
and a temperature distribution which was generated by catheter 28 of the present invention,
with shaft 32 inserted into a Polyacrylamide gel formulation which simulates biological
tissue. The formulation and preparation procedures for the Polyacrylamide gel are
discussed in detail in D. Andreuccetti, M. Bini, A. Ignesti, R. Olmi, N. Rubino, and
R. Vanni,
Use of Polyacrylamide as a Tissue-Equivalent Material in the Microwave Range, 35 IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING 275 (No. 4, April 1988). Fig. 6 shows
temperature measurements taken from eight temperature sensors. Four sensors were aligned
at fixed distances adjacent first side 68. Sensor 1A was positioned immediately adjacent
shaft 32; sensor 1B was positioned about 0.66 cm from shaft 32; sensor 1C was positioned
about 1.33 cm from shaft 32; and sensor 1D was positioned about 2.0 cm from shaft
32.
[0029] Four sensors were also aligned at fixed distances adjacent second side 72. Sensor
2A was positioned immediately adjacent shaft 32; sensor 2B was positioned about 0.66
cm from shaft 32; sensor 2C was positioned about 1.33 cm from shaft 32; and sensor
2D was positioned about 2.0 cm from shaft 32.
[0030] The x-axis represents a relative period of time over which the microwave thermal
therapy procedure was performed. The y-axis represents temperature in degrees Celsius,
with horizontal line H representing 45° C (the temperature at or above which cells
are necrosed).
[0031] As generally shown in Fig. 6, the microwave thermal therapy procedure of the present
invention includes five operating phases, P1 - P5. Lines 1A-1D and 2A-2D correspond
with sensors 1A-1D and 2A-2D, respectfully. During first phase P1, cooling system
36 is turned on and chilled water is pumped through cooling lumens 64A, 64B and 66A,
66B. A drop in temperature immediately adjacent shaft 32 is represented by lines 1A,
2A. At the end of first phase P1, cooling system 36 is turned off. At the beginning
of second phase P2, a relatively small amount of power (about 5 watts) is applied
to microwave antenna 74. The temperature immediately adjacent shaft 32 rises asymmetrically
due to the greater absorptivity of water in the larger exhaust lumens 66A, 66B on
second side 72, as shown by lines 1A, 2A. The power is applied long enough to merely
warm adjacent tissue to about 40°C. By the end of second phase P2, temperatures generally
return to base line temperature.
[0032] In a preferred embodiment of the present invention, the tissue responses to the chilling
during P1 and the heating during P2 aid in determining the vascularity of the tissue
to be treated. This information aids in determining the amount of power necessary
to treat tumorous tissue of prostate 14.
[0033] At the beginning of third phase P3, cooling system 36 is again turned on thereby
pumping chilled water through cooling lumens 64A-66B. The temperature immediately
adjacent shaft 32 correspondingly drops as indicated by lines 1A, 2A. Prechilling
of the tissue immediately adjacent shaft 32 aids in protecting the tissues immediately
adjacent shaft 32 (i.e., urethra 10) from overheating due to a relatively rapid application
of power from antenna 74.
[0034] Microwave generating source 38 is again turned on at the beginning of fourth phase
P4 at a sustained power output of about 20 watts. As shown in Fig. 6, due to the absorptivity
differential between water in the narrower intake lumens 64A, 64B and water in the
wider exhaust lumens 66A, 66B, temperatures adjacent second side 72, represented by
lines 2A-2D, are cooler than temperatures adjacent first side 68, represented by lines
1A-1D. The temperature differentials are most profound within a target volume of tissue
0.66 cm from shaft 32. Within this target volume, as shown by lines 1A, 2A and 1B,
2B, the difference in temperature from first side 68 and second side 72 is on the
order of about 10°C. Thus, by adjusting cooling system parameters or power output
from microwave generating source 38, tissue within 0.66 cm of first side 68 can be
heated to temperatures at or above about 45°C, while tissue within 0.66 cm of second
side 72 can remain at temperatures substantially below 45°C. In this manner, tissue-necrosing
temperatures within the target volume are essentially restricted only to tissue near
first side 68, which is the most frequent location of periurethral tumorous prostatic
tissue. Alternatively, by adjusting the power output or cooling system parameters,
a relatively small volume of tissue adjacent second side 72 can be heated above about
45°C to necrose some of the tumorous prostatic tissue which is posterior and lateral
to the urethra. In the preferred embodiment, during fourth phase P4, microwave generating
source 38 is operated for at least about 45 minutes.
[0035] As shown by lines 1A, 2A, during P4, the temperature of tissue immediately adjacent
shaft 32 (which is representative of temperatures of urethra 10), as well as temperatures
of tissue beyond 0.66 cm from shaft 32, as shown by lines 1C, 2C and 1D, 2D, are maintainable
well below 45°C. This is accomplished by adjusting cooling system parameters and,
if necessary, power output from microwave generating source 38.
[0036] At the end of fourth phase P4 power is turned off. At the beginning of fifth phase
P5, cooling system 36 continues to operate, circulating water through cooling lumens
64A-66B. A temperature drop immediately adjacent shaft 32 is relatively rapid as shown
by lines 1A, 2A within P5. In a preferred embodiment of the present invention, cooling
system 36 continues to operate for a period of time (on the order of 10 to 120 minutes)
after the procedure to cool urethra 10 and reduce edema resulting from the application
of heat to the periurethral tissues of prostate 14. In an alternative embodiment,
water feed line 94B, water return line 96B and thermometry sensor 69 (as shown in
Fig. 2A) are disconnected from connection manifold 35. Water feed line 94B and water
return line 96B of catheter 28 are then connected to another cooling system similar
to cooling system 36 and water is then circulated through cooling lumens 64A-66B in
a manner similar to that previously described. In this fashion, recovery from the
previously described procedure can be accomplished away from the treatment area thereby
enabling microwave generating source 38 and cooling system 36 to be readily available
for treatment of another patient.
[0037] Fig. 7 shows a partial sectional view of microwave antenna 74 of the present invention.
Antenna 74 is positioned at a proximal-most end of shielded coaxial cable 76. Cable
76 is a standard RG 178U coaxial cable and includes inner conductor 120, inner insulator
122, outer conductor 124, and outer insulator 126. Outer insulator 126, outer conductor
124 and inner insulator 122 are stripped away to expose about 3 millimeters of outer
conductor 124, about 1 millimeter of inner insulator 122 and about 1 millimeter of
inner conductor 120. Capacitor 128 includes first end 130, which is connected to inner
conductor 120 by soldering, and second end 132, which connects to antenna 74. Capacitor
128 serves to counteract a reactive component of antenna 74, thereby providing a 50
ohm match between coaxial cable 76 and microwave generating source 38, and antenna
74.
[0038] Tubular extension 134, which is a hollow section of outer insulator 126 of coaxial
cable 76, is positioned over capacitor 128 and the exposed length of inner insulator
122 and secured by bond 136. Tubular extension 134 includes hole 138, which provides
an exit for second end 132 of capacitor 128. Wound about outer insulator 126 and tubular
extension 134 is flat wire 140. Flat wire 140 is a single piece of flat copper wire
with dimensions of about 0.229 mm (0.009 inch) by about 0.813 mm (0.032 inch) in cross-section,
which provides a relatively large surface area for maximum current flow while minimizing
the cross-sectional size of antenna 74.
[0039] Fig. 8 is an exploded view of a portion of antenna 74 which shows its helical dipole
construction. Generally, the efficiency of any dipole antenna is greatest when the
effective electrical length of the antenna is generally one half the wavelength of
the radiation emitted in the surrounding medium. Accordingly, a relatively efficient
simple dipole antenna, operating at about 915 MHz, would require a physical length
of about 8 centimeters which, according to the present invention, would needlessly
irradiate and damage healthy tissue. Furthermore, the physical length of a relatively
efficient simple dipole antenna operating at about 915 MHz cannot be varied.
[0040] As shown in figure 8, flat wire 140 is soldered to outer conductor 124 at solder
point 146. Flat wire 140 is then wound in a distal direction about outer insulator
126 and in a proximal direction about tubular extension 134, thereby forming first
wire section 142 and second wire section 144, both of which are of equal length. In
one embodiment, first and second wire sections 142 and 144 are each comprised of eight,
equally-spaced windings of flat wire 140. The combined length of first and second
wire sections 142 and 144, and hence the overall length of antenna 74, ranges from
about 1.5 centimeters to about 4.0 centimeters, and varies according to the length
of the area of prostate 14 which requires treatment. A standard medical-grade silicone
tube (not shown), which has been allowed to soak in a solvent, such as Freon, is positioned
over first and second wire sections 142 and 144. As the solvent evaporates, the silicone
tube shrinks, thereby securing flat wire 140 to outer insulator 126 and tubular extension
134.
[0041] The helical dipole construction of the present invention, allows antenna 74 to range
in physical length from about 1.5 to 4 centimeters, while electrically behaving like
an eight centimeter-long simple dipole antenna. In other words, antenna 74 has an
effective electrical length generally equal to one half of the wavelength of the radiation
emitted in the surrounding medium, independent of its physical length. For purposes
of definition, the surrounding medium includes the catheter shaft and the surrounding
tissue. This is accomplished by varying the number and pitch of the windings of first
and second wire sections 142 and 144. A family of catheters, which contain relatively
efficient helical dipole antennas of different physical lengths, permits selection
of the antenna best suited for the particular treatment area. In addition, antenna
74 of the present invention is capable of producing a constant heating pattern in
tissue, concentrated about antenna 74, independent of the depth of insertion into
the tissue.
[0042] Second end 132 of capacitor 128, which exits hole 138, is soldered to second wire
section 144 at tap point 148, as shown in Fig. 7. Tap point 148 is a point at which
the resistive component of the combined impedance of first wire section 142 and second
wire section 144 matches the characteristic impedance of coaxial cable 76. The impedance
of either first wire section 142 or second wire section 144 is expressed as
Z, where
Z = R + jX. The impedance
Z varies from a low value at solder point 146 to a high value at a point farthest from
solder point 146. There exists a tap position where
R is equal to 50 ohms, but an imaginary component,
X, is inductive. This inductive component can be canceled by inserting a series capacitance,
such as capacitor 128, which has a value of -jX ohms. This results in an impedance
match of 50 ohms real. The resulting method of feeding antenna 74 is commonly called
gamma matching. In one embodiment of the present invention, where the physical length
of flat wire 140 is about 2.8 cm, tap point 148 is about 3.5 turns from solder point
146 on second wire section 144. In the preferred embodiment, the value of capacitor
128 is about 2.7pF.
[0043] The helical dipole construction of antenna 74 achieves a relatively small size, which
permits intraurethral application. The helical dipole construction is also responsible
for three features which enable antenna 74 to achieve greater efficiency than prior
known interstitial microwave antennas: good impedance matching, good current carrying
capability and an effective electrical length which is generally one half of the wavelength
of the radiation emitted in the surrounding medium, independent of the physical length
of antenna 74.
[0044] First, the good impedance match between antenna 74 and inner conductor 120 minimizes
reflective losses of antenna 74, with measured reflective losses of less than 1% in
a preferred embodiment. Second, the use of flat ribbon wire 140 for first wire section
142 and second wire section 144 minimizes resistive losses of antenna 74 by providing
a greater surface area upon which RF current can be carried. Finally, the helical
dipole design of antenna 74 has an effective electrical length which is generally
one half of the wavelength of the radiation emitted in the surrounding medium, independent
of the physical length of antenna 74. This permits the physical length of antenna
74 to be varied to accommodate varying sizes of individual prostates while maintaining
the same efficient, effective electrical length of antenna 74.
[0045] The use of an efficient microwave antenna is critical to the ability to focus thermal
energy a distance from the antenna within a target volume. An inefficient antenna
produces a lesser intensity of microwave radiation within the target volume than desired.
It also produces undesired heat close to the urethra, which will damage the urethra
if not carried away by an increased coolant flow. This added burden on the cooling
system reduces its capacity to protect the urethra, thereby limiting the microwave
power that can be radiated without elevating urethra temperatures above safety limits.
With microwave power limited by cooling system capacity, the heat delivered to the
desired target area of the prostate will not be sufficient for effective therapy.
The efficient helical dipole design of antenna 74 of the present invention, however,
ensures that almost all heat delivered during the treatment is delivered in the form
of microwave energy, rather than conductive heat energy.
[0046] Fig. 9 is a block diagram of transurethral microwave thermal therapy system 170,
with which urethral catheter 28 is used. System 170 includes cooling system 36 microwave
generating source 38, user interface 172, real time controller (RTC) 174, directional
coupler 176, thermometry sensors 182 and 184, coolant pressure sensor 186, balloon
inflation device 188, and urine collection container 190.
[0047] As shown in Fig. 9, control of microwave generating source 38 and cooling system
36 is effected by real time controller 174, which is in turn controlled by user interface
172. User interface 172 is an IBM compatible machine containing two hard drives for
data storage: one for backup, and one for normal operation of system 170. User interface
172 communicates with RTC 174, which is responsible for all closed loop feedback to
run system 170. RTC 174 has direct closed loop control of microwave power from microwave
generating source 38, and coolant flow and coolant temperature of cooling system 36.
Closed loop feedback tracks out variations in gain, drift and cable losses inherent
in microwave generating source 38, and variability in pump output and refrigeration
system efficiency of cooling system 36. In addition to monitoring microwave generating
source 38 and cooling system 36, RTC 174 also monitors and controls several channels
of thermometry via inputs from thermometry unit 178. Cooling system thermometry 178A
measures the coolant and chiller temperatures based upon signals from coolant temperature
sensors 182 and 184 and a chiller temperature sensor (not shown) of cooling system
36. Urethral thermometry 178B measures urethral temperature based upon signals from
temperature sensor 69 within catheter 28. Rectal thermometry 178C measures rectal
temperature based upon signals received from a sensor (not shown) within rectal probe
180.
[0048] RTC 174 transmits all closed-loop feedback to user interface 172, which processes
the input and transmits corrections and instructions back to RTC 174. RTC 174 interprets
the instructions given to it by process control language received from user interface
172 and executes the instructions in real time. All corrections from user interface
172 are made to maintain a given thermal profile throughout the transurethral thermal
therapy. In addition, system 170 includes a hardware fail-safe circuit which shuts
down system 170 should any parameter fall outside a given range of values.
[0049] While the beneficial uses of the microwave antenna-containing catheter of the present
invention have been described with respect to the urethra, other intracavitary applications
are implied.
[0050] Although the present invention has been described with reference to preferred embodiments,
workers skilled in the art will recognize that changes may be made in form and detail
without departing from the spirit and scope of the invention, as defined by the claims.